The European Commission has granted a marketing authorisation in the EU for Zaltrap to treat adults with metastatic colorectal cancer that is resistant or has progressed after initial treatment.

The decision was based upon evidence from Phase III trial data which showed Zaltrap to be the first and only agent to statistically significantly improve survival in combination with FOLFIRI chemotherapy after an oxaliplatin regimen.

Colorectal cancer is the most common cancer in both men and women in Europe and is the second leading cause of cancer death.

The treatment is marketed by Sanofi and Regeneron Pharmaceuticals.

Dr Debasish Roychowdhury, Senior Vice President and Head, Sanofi Oncology, thanked “physicians, patients and their families” for their efforts in getting the injection approved.

“We are thrilled to provide a new therapy that further extends the lives of patients with metastatic colorectal cancer and look forward to working with European health authorities to ensure patients have access to Zaltrap,” he said.

Dr George Yancopoulos, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories, added that the treatment “provides a new option to address the unmet medical need” across Europe.

Zaltrap received approval by the US FDA back in August 2012 following a priority review by the agency. It is also under review with other health regulators across the world.

Biotechnology giant MedImmune has appointed Bahija Jallal, its current Executive Vice President for R&D, as its new President.

The former President of the Maryland-based company, Peter Greenleaf, will take over leadership of parent company AstraZeneca’s (AZ) Latin American business.

The transition accompanies the formal designation of MedImmune as the global biologics division of AZ, which acquired it for $15.6bn in 2007.

Bahija Jallal is a former researcher at the Max-Planck Institute of Biochemistry in Germany. While VP of Drug Assessment and Development at Chiron, she was headhunted by MedImmune in 2006, becoming its Head of Translational Science.

Commenting on that appointment, Jallal said: “I was struck by MedImmune’s history of innovation. And I looked at who they had on their board of directors and their executives. There were more women than you would see at other companies.”

The fortune paid by AZ to acquire MedImmune surprised many in the industry. The acquisition was followed by investment in its R&D capability, including the development of a new site in Cambridge, England, and the merger of the UK group with Cambridge Antibody Technology.

According to MedImmune spokesman Mike O’Brien, the biotech company’s commercial operation now formally belongs to AZ’s North American business, while its manufacturing operation is part of AZ’s global operations.

“The driver for these changes is not cost but even faster decision-making in key areas of the business and a need to reduce complexity,” he said.

Through MedImmune, AZ plans to deliver an average of one new biologic drug per year from 2013.

MedImmune’s past successes include two innovative vaccines: the first monoclonal antibody approved by the FDA for use against an infectious disease (Synagis, used to prevent the childhood lung disease RSV); and the first intranasal vaccine against influenza (FluMist).

The largest manufacturer of the generic version of Lipitor has been forced to halt production after glass particles were found in certain batches of tablets.

The US FDA announced that Ranbaxy Pharmaceuticals had ceased production of atorvastatin after fragments the size of sand contaminated the popular generic.

Ranbaxy, a subsidiary of Daiichi Sankyo, said “the probability of an adverse event due to consumption of this product is unlikely but cannot be ruled out.”

More than 40 batches of the generic have now been recalled, although the FDA said it had not received any reports of patients being harmed by the contamination.

The New Jersey-based company (part of India-based Ranbaxy Laboratories) declined to reveal where the contaminated drugs were manufactured or why the problem occurred. However, the FDA said that the company has now stopped making the pill’s active ingredient – which is made in India – until an investigation has been completed.

It is not the first time that the quality of Ranbaxy’s products has come under scrutiny. The company has been working under a US court-ordered consent decree after a number of manufacturing issues were found at sites in America and in India. The decree prevents Ranbaxy from producing any more medication at these sites until it meets US standards.

Ranbaxy became one of the first generic manufacturers of the cholesterol lowering Lipitor when the blockbuster drug lost patent protection in November 2011. It now holds a market share of approximately 43%, according to IMS Health data.

Eisai is celebrating after The All Wales Strategic Medical Group (AWSMG) and Scottish Medicines Consortium (SMC) backed a drinkable version of Inovelon (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

The oral suspension can be used in children aged four and over who have failed treatment with, or are intolerant of, other antiepileptic drugs.

Mike Bee, Epilepsy Business Unit Director, EU North, Eisai, said approval of the medication was important to “help address the adherence needs of children and young people.”

LGS is a severe form of epilepsy which accounts for between 5%-10% of childhood cases.

The decision to approve the treatment follows the approval of the tablet formulation by both authorities in 2008. That approval was based on data which showed Inovelon can significantly reduce the frequency of total and tonic-atonic seizures and improve seizure severity.

The oral alternative was shown to be bioequivalent and cost-effective in Scotland and Wales.

Inovelon – in an oral form – received positive CHMP opinion in September last year and was granted EMA approval in November 2011. It was launched in the US in March 2011 marketed as Banzel.

Several generic versions of BMS’s blockbuster blood thinning drug Plavix (clopidogrel) have been released in the US after patent protection expired.

The FDA has approved a number of manufacturers that are now able to supply the treatment, which generated sales of $6.8 billion in the US last year for BMS and its partner Sanofi.

BMS, which earned a third of its revenue from Plavix, said last week it would no longer promote the drug following the loss of patent protection.

However, it will reduce the monthly cost of the treatment from $100 to $37 in an attempt to hold some market share, according to the Wall Street Journal.

Mylan Pharmaceuticals is in the driving seat to take advantage of BMS’ loss with the generic manufacturer ready to ship its products across the country.

Alongside Mylan, Teva, Apotex, Aurobindo Pharma, Roxane Laboratories, Sun Pharmaceuticals Industries, Torrent Pharmaceuticals, Dr Reddy’s Laboratories and Gate Pharmaceuticals have also been approved by the FDA to supply clopidogrel.

The FDA has said that MS drug Gilenya (fingolimod) should not be used in patients with a recent history of stroke or heart disease.

The requested label change adds to changes requested by the EMA and the FDA in April to reduce the risk of cardiovascular and neurovascular events.

The FDA also concluded that a number of sudden deaths in patients with severe MS taking Gilenya could not be conclusively linked to the drug.

Gilenya was recommended by NICE in late April as a “valuable new therapy” for severe relapsing-remitting MS.

The new FDA safety review reinforced the earlier recommendation that doctors monitor the heart rate of patients taking Gilenya for the first time.

However, it said that the death of a 59-year-old patient in November after a first dose of Gilenya could have been caused by the patient’s advanced brainstem MS lesions and not by the drug.

In other cases of sudden death in patients taking Gilenya, it said, the drug’s “contribution to the death was unclear”.

However, the FDA definitely recommended not using Gilenya in patients who have suffered a stroke or heart disease within the previous six months, or who are taking certain medications for cardiac arrhythmia.

Gilenya was approved in the US in 2010 and in the EU in 2011, and remains the only oral MS drug on the market.

The first proven drug for prevention of HIV infection has been recommended for FDA approval by an expert panel.

Truvada from Gilead Sciences, an oral combination therapy used since 2004 to treat HIV infection, may shortly be available as a preventative therapy.

The panel emphasised that the drug is less effective in women than in men, and must not be used in place of other preventative strategies.

Adherence was also highlighted as an issue, since Truvada is ineffective if not taken every day.

Truvada was recommended for prescription to people at high risk of HIV infection, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The medication is a combination of two anti-HIV drugs, Emtriva and Viread. Its off-label use to prevent HIV infection is already widespread.

In 2010, a three-year study by the US government found that daily doses of Trevada together with condom use reduced the risk of HIV infection by 42% in gay and bisexual men. In 2011, a similar study found that it reduced infection by 75% in heterosexual couples where one partner was HIV-positive.

The drug’s value is contested among people working to control HIV infection, due to concerns that Trevada will give people who are not compliant with the need for condom use and/or daily dosage a false sense of security.

While the cost of widespread prescription is not a factor in whether the FDA grants marketing approval for Trevada, it will clearly affect its uptake by health workers relative to other strategies.

Shares in Arena Pharmaceuticals increased in price by 80% after advisors to the FDA backed the approval of the obesity drug lorcaserin.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted in favour of recommending lorcaserin after deciding data demonstrated that benefits outweighed long-term risks.

Jack Lief, Arena CEO, said the decision “supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity”.

The Prescription Drug User Fee Act (PDUFA) date for the FDA’s final decision on lorcaserin is now expected on 27 June.

Lorcaserin was initially rejected by the FDA back in 2010 when concerns were raised over its clinical effectiveness and around its side-effects.

Arena refiled the drug at the end of 2011 with new data ruling out excessive risk of valvular heart disease.

The decision on Lorcaserin comes a month after the same committee supported the use of Vivus’ rival obesity drug Qnexa (phentermine/topiramate) with its PDUFA data extended from April 17 to July 17.

Contrave (naltrexone/bupropion), another rival weight loss drug from Orexigen Therapeutics and Takeda, is currently being evaluated in a cardiovascular outcomes trial after it was rejected by the FDA over heart risks.

After the positive decision by the FDA’s advisors, Arena and its marketing partner Eisai expanded their marketing and supply agreements for the treatment to cover the US, Canada, Mexico and Brazil.

Cell Therapeutics has gained conditional authorisation from the European Commission to market its treatment for non-Hodgkin’s B-cell lymphoma.

The US biopharma company will be able to market Pixvuri (pixantrone) through a named patient programme in the EU.

This type of authorisation allows a company to quickly market a drug that addresses a major unmet medical need, while waiting for full approval.

According to Cell Therapeutics, the decision follows a phase III clinical trial that showed Pixvari to offer longer progression-free survival and a higher rate of complete response than chemotherapy.

Cell Therapeutics plans to commercialise Pixvari in Europe in the second half of 2012, and will need to complete a post-marketing study to confirm the drug’s clinical efficacy.

The EC decision is a breakthrough for the product, which was rejected by the FDA in 2011 on the grounds that its benefits were unproven. The company is preparing for a second FDA committee review.

The FDA and the EMA are to review Biogen Idec’s marketing application for BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS).

BG-12 is the only known investigational compound for the treatment of MS that has experimentally demonstrated activation of the Nrf-2 pathway.

It has demonstrated significant reductions in MS disease activity, coupled with favourable safety and tolerability in two separate Phase III clinical trials.

Last year, Biogen published data from the DEFINE and CONFIRM global clinical trials that demonstrated BG-12’s effectiveness in patients taking the treatment either twice or three times a day over a period of two years.

As a result, the FDA has now accepted Biogen’s New Drug Application and granted the company a standard review timeline. In addition, the EMA has validated a similar application for review.